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User Fees

FDA and the drug industry have agreed on performance goals for the sixth iteration of the drug user fee law that echo key objectives of the House-passed 21st Century Cures Act, including: enhancing adaptive, Bayesian and other clinical trial designs, incorporating the patient voice in drug development and enhancing the review of combination products.

FDA device chief Jeffrey Shuren made a public case for a national device evaluation system in a July 11 article in a prominent medical journal that says adding unique device identifiers to claims forms and securing industry funding are key to the effort.

The American Academy of Pediatricians (AAP) says its near decade-long press for FDA to establish safety and efficacy of over-the-counter cough and cold products for children shows a dire need to reform the OTC monograph process and increase agency resources through a user fee program.

FDA recently kicked off discussions on developing a user fee program for over-the-counter (OTC) drug products, expounding on the lack of resources the agency has to finish outstanding monographs with a staff of only 18 full-time employees regulating a market of more than 100,000 products.

FDA and the medical device industry continue to disagree on key issues as discussions continue on how to craft the next device user fee law, according to minutes of an April 27 meeting between the parties.

FDA will hold a public meeting on June 10 to explore setting up a user fee program to help fund reviews of over-the-counter (OTC) drug monographs, saying the agency's OTC program is severely under resourced and reviews could stall.

Key medical device lobby groups told FDA at a recent meeting that the agency's high-priority goals for the next user fee law don't match industry's, and said their members oppose the agency's real-world evidence funding plan and other proposals they believe are not worth the investment and don't fit into the scope of the user fee program, according to minutes from the March meeting.

FDA drug chief Janet Woodcock gave a small opening to the agency factoring drug price spikes in how it queues generic drug approvals, telling a Senate panel Thursday that such a policy might be possible if HHS came up with a “bullet proof” way of defining a price spike.

FDA drug center chief Janet Woodcock told the Senate health committee Thursday (Jan. 28) that the agency will “absolutely” have the generic drug application application backlog cleared out when the current Generic Drug User Fee Amendments (GDUFA) expire at the end of September 2017.

Drug industry stakeholders floated the idea of offering “third-party support” to help implement improvements to FDA's hiring system that would positively impact the sixth iteration of the Prescription Drug User Fee Act (PDUFA), and the agency said it would consider the suggestion, an FDA document reveals.

Energy and Commerce Committee Chair Fred Upton (R-MI) praised the spending package passed last week saying that it provided FDA with an increase near to what the 21st Century Cures Act sought in fiscal year 2016.

FDA coordinated with the medical device lobby on a CEO survey of policies in play under the third device user fee law, according to internal documents and emails obtained by Inside Health Policy through the Freedom of Information Act.

As lawmakers debate how much funding to provide FDA in 2016 and the drug and device user fees talks enter the substantive stages, millions of dollars gathered from previous user fee agreements sit in the Federal Treasury as a result of a previous legal glitch, industry representatives say.

Key issues are starting to emerge as FDA and the medical device industry gear up to present their user fee proposals next Wednesday (Nov. 18) at a closed-door meeting that is expected to jump-start preliminary discussions on reauthorization of the user fee agreement set to expire in 2017.

Seventy-two percent of device postmarket approval and surveillance studies mandated by FDA between 2008 and 2015 are sill ongoing, according to a recent report from the Government Accountability Office.

As uncertainty grows around the Senate health committee's effort to move its own parallel version of the House Cures legislation, the drug and device industries are increasingly looking to upcoming user fee reauthorization bills as vehicles for policy changes to FDA, industry sources say.

FDA says it is well ahead of schedule in tackling the backlog of generic drug applications, as a rising chorus of voices, including Democratic presidential candidate Hillary Clinton, press the agency to clear the backlog to help counter rising pharmaceutical prices.

FDA officials repeatedly have said some provisions of the House's 21st Century Cures bill would be better left to the Prescription Drug User Fee Act (PDUFA) reauthorization process without giving specifics, but sources say while the two inform each other industry is addressing each separately.